NASDAQ: BSGM
BioSig Technologies, Inc. (NASDAQ: BSGM) is a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals within the rapidly growing $4.6 billion electrophysiology (EP) marketplace. Led by a proven management team, world-class Board of
Directors and Scientific Advisory Board, Los Angeles-based BioSig is preparing to commercialize its PURE EP™ System. PURE EP™ is a signal acquisition and processing system designed to assist electrophysiologists in making clinical decisions in real-time to help identify areas of tissue that create a heart rhythm disturbance (arrhythmia). PURE EP™ is designed to support catheter ablation cases, working in parallel with existing recording and mapping systems. BioSig's goal is to improve the standards of care in electrophysiology and increase the number of patients who can have their condition successfully treated during the first procedure.
Key Growth Drivers
- Advanced Technology - The non-invasivePURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The PURE EP System aims to minimize noise and artifacts, and acquire high-fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and ablation procedures. The PURE EP™ System received FDA 510(k) clearance in August
2018. - Market Opportunity - Market Research Engine states the global electrophysiology (EP) device market is expected to exceed more than US $8.5 billion by 2024 and is growing at a compound annual growth rate (CAGR) of 10.6%. The Company also operates within the rapidly emerging field of bioelectronic medicine, estimated at $3.75 billion in 2017 with projected annual growth of 14.2%.
- KOL Support - First successful clinical use of PURE EP™ System was led by two globally recognized leaders: Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute and Prof. John M. Miller of Indiana University. The Company achieved proof of concept validation through UCLA, and performed eighteen pre-clinicalstudies at Mayo Clinic, MN under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic's Vice-Chairof Innovation and Medical Director, Electrophysiology Laboratory.
Market Snapshot
NASDAQ: BSGM
Price (1/03/20) | $6.14 |
Average | 75,681 |
Volume (50 day) | |
52-Wk. Range | $4.06 - |
$9.97 | |
Float | 16.24M |
Shares | 22.17M |
Outstanding | |
Market Cap | $136.13M |
Recent Highlights
- Announced partnership with Reified on development of artificial intelligence (AI) solutions in healthcare
- Commenced its first clinical trial for its PURE EP™ System
- Opened a technology development office in Rochester, Minnesota
- Signed a new licensing agreement with Mayo Clinic in Sept. '19 - 3 new agreements signed in Nov '19
- BioSig's subsidiary NeuroClear Technologies, Inc. raised $3.7 million in an initial seed round
- Allowed additional foundational US Patent for its PURE EP™ System
- Appointed five new senior industry hires: Andrew Ballou - Vice President of Investor Relations; Julie Stephenson, BSN, MBA - Senior Director of Clinical Affairs; Olivier Chaudoir - Director of Marketing; Manasi Patwardhan - Director of Strategic Planning; Sasha Gentling, CFA - Director of Business Development and Investments
- Added as a member of the Russell 3000® Index
- Appointed Jerome Zeldis, M.D., Ph.D,, Samuel E. Navarro, and Martha Pease to Board of Directors
- Received $4.6 million in cash warrant and option exercises
- Announced that the US Patent & Trademark Office allowed 33 patent claims covering its PURE EP™ System
- Successfully conducted patient cases using PURE EP™ System at Indiana University School of Medicine, Texas Cardiac Arrhythmia Institute and Greenville Memorial Hospital
BioSig Technologies, Inc.
Contact:
Kenneth L. Londoner
Phone: +1 (203) 409-5444, x119 klondoner@biosigtech.com
Investor Relations
Phone: +1-310-620-9320 ir@biosigtech.com
Investment Catalysts
PURE EP™ System | Proven Team | Investment Highlights | |||||||||||||
Proprietary Hardware and Software with | BioSig is comprised of a stellar cast of a | • Member of the Russell 3000® Index | |||||||||||||
Advanced Signal Processing Capabilities: | proven | management | team | and | a | premier | • | Successfully Conducted First Patient Cases with | |||||||
• To Improve Signal Clarity Through Reduction | Board of Directors with high levels of inside | PURE EP™ | |||||||||||||
• | Management and | Insiders | Own Approx. 68% | of | |||||||||||
of 'Noise' and Artifacts | equity ownership. | ||||||||||||||
Shares | |||||||||||||||
• To Minimize Need for Repeat Procedures | BioSig | brought | together leading | physicians, | • 10-year Strategic Collaboration with Mayo Clinic | ||||||||||
• To Preserve Important Clinical Information | • Core competency in Basic Science, Capital Markets | ||||||||||||||
executives | and | engineering | experts from | and Capital Architecture | |||||||||||
• To Shorten Procedure Times | |||||||||||||||
leading medical centers of excellence, | • | IP Strategy Led by Sherpa Technology Group and | |||||||||||||
• To | Increase Confidence | in Performing | healthcare programs, Fortune 500 Companies | Sterne Kessler Goldstein & Fox | |||||||||||
Complex Ablations | and elite | educational institutions | including | • FDA clearance achieved; CE Mark-2020 | |||||||||||
• Proven Management Team and Board of Directors | |||||||||||||||
Mayo | Clinic, Mount | Sinai Medical | Center, | ||||||||||||
• Global and Growing Addressable Market | |||||||||||||||
UCLA, | Johnson | & | Johnson, Nasdaq | and | |||||||||||
• | Operates Within | Rapidly | Emerging Field | of | |||||||||||
Prudential Securities. | |||||||||||||||
Bioelectronic Medicine | |||||||||||||||
Kenneth L. Londoner, Chairman & CEO, has a | • High-GrowthSector Earns | Innovation Premium, | |||||||||||||
Aggressive M&A | |||||||||||||||
wealth of knowledge and experience that | Collaborating with Leading EPs from: | ||||||||||||||
spans many decades and includes founding, | |||||||||||||||
Global | EP Market-10.6% | Growth from | running, and serving as Director to a number | ||||||||||||
of life science companies. Mr. Londoner began | |||||||||||||||
2016-2024 reaching $8.5B by 2024 | |||||||||||||||
his career with J. & W. Seligman & Co., Inc., a | |||||||||||||||
• Global Ablation: 865,000 patients in 2015 to | |||||||||||||||
leading institutional money management firm | |||||||||||||||
1,350,000 in 2020. | where | he | rose | from research | analyst | to |
- Global Procedure Growth: 8.4% annual rate, managing $3.5 billion in mutual funds,
from 973,220 in 2017 to 1,455 million in | pension funds, and international assets. Steve | ||||
2022. | Chaussy, CFO has acted as a consultant for | Current Cardiac Arrhythmia Epidemic (1 in 18 or | |||
• The FDA (www.fda.gov) presented at the Heart | small publicly | traded entities | with a special | ||
14.4M Americans) | |||||
Rhythm Society 2017 | and spoke of the | emphasis towards SEC reporting and | |||
Two of the most prevalent and potentially deadly | |||||
compliance; and served as CFO for a large | |||||
importance of technological innovation in the | |||||
private distribution and wholesaling company, | types of arrhythmias today are Atrial Fibrillation | ||||
EP field. | |||||
(AF) and Ventricular Tachycardia (VT). Ventricular | |||||
where he gained international experience. | |||||
arrhythmias account for approximately 450,000 | |||||
Their many accomplishments | and years of | sudden deaths per year in the United States | |||
alone. Catheter ablation is fast becoming a first | |||||
experience of the management team, as well | |||||
line therapy, driving demand for improved | |||||
as the Board | of Directors | and Scientific | |||
technologies. AF is the most common arrhythmia | |||||
Advisory Board, is unmatched and provides | affecting 33.5 million people worldwide, with as | ||||
BioSig a clear advantage in the market. | many as 6.1 million people in the U.S. now and | ||||
expected 8-12 million by 2050. AF increases the | |||||
risk of stroke 4x to 5x and contributes to | |||||
~750,000 hospitalizations per year. The direct | |||||
Management | Directors | cost of AF is approximately $6B annually; adding | |||
other indirect costs brings AF total cost to $26B. | |||||
Kenneth L. Londoner, MBA, Founder, Chairman, Chief | |||||
Donald E. Foley, Director - CEO & Chair: Wilmington Trust; Sr VP, Treas & Dir: ITT Corp; Asst | |||||
Executive Officer, Director | |||||
Treas: International Paper Co. | |||||
Endicott Management Partners; J & W Seligman & Co; Director: Alliqua | David Weild IV, MBA, Director - Current Chairman & CEO; Weild & Co.; Vice Chairman: | ||||
Steve Chaussy, CPA, Chief Financial Officer | |||||
NASDAQ; Head of Corporate Finance & Equity Markets: Prudential Securities | |||||
Liberski Inc; Anna & Co; Penske Truck Leasing, Ford, Hogg & Cobbe | Patrick J. Gallagher, MBA, Director - Mg Dir: Laidlaw & Co.; Kinex Pharmaceuticals; | ||||
Natasha Drapeau, Executive Vice President | Director: Cingulate Therapeutics, BDR Research Group, GC Capital Partners, Kidder Peabody | ||||
Jeffrey F. O'Donnell, Sr., Director - Current CEO, Director: Trice Medical; Current Chair: | |||||
IG Group Plc, London, UK; Augeous Consulting, Geneva, Switzerland | |||||
SpectraWave; Director: AdvaMed Accel; Founder: Embrella Cardiovascular (sold to Edwards | |||||
Barry Keenan, Ph.D, MBA, PMP, VP, Engineering | |||||
Lifesciences); CEO: PhotoMedex, Radiance Medical (Cardiovascular Dynamics), Kensey Nash; | |||||
Medtronic, Nexeon MedSystems, Alfred Mann Institute for Biomedical | Sales/Mktg Mngt: Boston Scientific, Guidant, J&J; Former Director: Cardiac Science, Endologix | ||||
Engineering; Alfred Mann Foundation for Scientific Research | Andrew Filler, Director - Current Partner & General Counsel: Sherpa Technology Group, | ||||
John Kowalski, VP, Sales | Nanosys; IP Counsel: Previvo Genetics; Board: Aira Technologies. Former: Caliper Life Sciences | ||||
Biosense Webster (Johnson & Johnson) | (sold to Perkin Elmer), Weil, Gotshal & Manges | ||||
Jerome Zeldis, M.D., Ph.D, Director - Chief Medical Officer and President of Clinical | |||||
Andrew Ballou, VP, Investor Relations | |||||
Research, Medical Affairs Drug Safety, Quality, and Regulatory at Sorrento Therapeutics, Inc. | |||||
Janney Montgomery Scott LLC., RBC Capital Markets | |||||
Samuel E. Navarro, Director - Managing Partner: Gravitas Healthcare, LLC; Former | |||||
Julie Stephenson, VP, Clinical Affairs | |||||
Managing Director and Global Head of Medical Technology Investment Banking: Cowen & | |||||
Medtronic, Boston Scientific, Guidant Corporation | Company | ||||
Olivier Chaudoir, Sr. Director of Marketing | Martha Pease, Director - Current Partner and Director at BCG (Boston Consulting Group) | ||||
Biosense Webster, DePuy Synthes | |||||
Analyst Coverage | ROTH Capital Partners | ||||
Laidlaw & Co (UK) Ltd. | Chardan Capital Markets, LLC. |
Disclaimer: This Corporate Summary Sheet includes forward-looking statements. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing, regulatory approvals, competition and marketplace demand. More information, and BioSig risk factors, are set forth in its filings with the SEC. BioSig assumes no obligation to publicly update or revise its forward-looking statements.
Attachments
- Original document
- Permalink
Disclaimer
Biosig Technologies Inc. published this content on 10 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2020 23:02:01 UTC